Pursuant to Section 7 (2) of the German Animal Welfare Act (Tierschutzgesetz, TierSchG), "animal testing" is understood to be procedures or treatments for experimental purposes on animals or their genetic material if they may involve pain, suffering or harm to these animals, their offspring or carrier animals. Furthermore, the term "animal testing" also includes procedures or treatments that do not serve experimental purposes. They are listed separately in Section 7 (2) sentence 2 and include, among other things, the removal of organs for transplantation purposes.

In 2002, animal protection in Germany was elevated to the status of a so-called state objective (Article 20a of the German Constitution). State objectives do not establish a subjective right and are not enforceable, but, like the fundamental rights, they nevertheless constitute constitutional goods. From a constitutional perspective, this circumstance legitimizes in principle the restriction of freedom of research through animal protection regulations. However, it remains controversial how the existing regulations on the official approval practice of animal testing are to be interpreted after the constitutional amendment, and to what extent animal protection as a state objective can actually restrict the unconditional fundamental right to freedom of research. Furthermore, on August 13, 2013 the Animal Welfare Ordinance on Laboratory Animals (Tierschutz-Versuchstierverordnung, TierSchVersV) came into force. This ordinance specifies conditions for the protection of laboratory animals (e.g. husbandry conditions) and rules for conducting animal testing.

The permissibility of animal testing is limited in Section 7a (1) TierSchG to particular purposes for which animal testing must be indispensable. This includes, for example, research into the treatment of diseases, protection of the environment or testing the safety of pharmaceuticals and foods.

Pursuant to Section 7 (1) sentence 3 TierSchG, animal testing may only be carried out by persons who have the "necessary knowledge and skills" for this purpose. The fifth section of the German Animal Welfare Act stipulates the conditions under which animal testing may be carried out and the extent to which they are subject to approval or mere notification. Experiments on vertebrates or cephalopods require a permit from the competent authority. The reservation of approval is anchored in Section 8 TierSchG and contains conditions that must be fulfilled for a successful approval. In addition to the indispensability of animal testing, particular attention is paid to the technical qualification of the persons conducting the testing with regard to the handling of laboratory animals and the husbandry conditions of the laboratory animals.
 Animal testing which meets the requirements of Section 8a (1) TierSchG and therefore does not require approval, but is merely notifiable, must be distinguished from this. This includes, for example, experimental projects on decapods (Section 8a (3)) as well as animal testing prescribed by law or statutory orders (Section 8a (1) No. 1).

Animal testing is expressly prohibited under German law for certain research objectives, e.g. "for the development or testing of weapons, ammunition and related equipment" (Section 7a (3)). In general, this prohibition also applies to animal testing "for the development of tobacco products, detergents and cosmetics" (Section 7a (4)); however, the law allows approvals in exceptional cases.